HKBio Partners With Brain Navi Biotechnology Co., Ltd. to Co-develop Robot-assisted Brain Endoscope

Founded by the Chairman John Hsuan 8 years ago, HKBio has spent years honing the expertise in regulatory consultation, product registration services, and contract design and development services for medical device products. HKBio has announced this month that it has partnered with Brain Navi Biotechnology to co-develop a robot-assisted brain endoscope, helping surgeons safely, swiftly and accurately to place endoscopes…

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Medtech Service Provider HuKui Bio raised US$5.5M for US market expansion

The medtech service provider Hukui Bio (互貴興業) announced that it has raised US$5.5 million in Series C funding, led by Yellowstone Holding AG from Switzerland, totalling US$11.8M funding to date. HuKui Bio will collaborate with venture capital funds in the Bay area, in addition to the biomedical innovation clusters and accelerators in Europe and the US. The New Business Department…

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“Made in China” is no longer attractive due to the U.S.-China trade war, suggesting that Taiwan’s CDMO industry for electronic medical devices is going to be more lucrative

A few days ago, I had visited Hukui Biotechnology Co., Ltd. (Hukui Bio) which was founded by John Hsuan with Michael Kuo, the current CEO. We talked about the latest development in the global electronic medical devices market and the evolution of professional electronic medical devices contract development and manufacturing organization (CDMO) industry since the US-China trade war. In recent…

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We Are Fighting The COVID-19 Threats !

In 2020, the epidemic of COVID-19 has spread in the whole world, and COVID-19 diagnostic kit is definitely a purchasing point from the beginning. Hukui Bio has been authorized bytwo Taiwan nucleic acid diagnostic kit factories to begin providing COVID-19 diagnostic kit for Europe, ASEAN and South America markets, hoping to satisfy their local medical resources.

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Cymmetrik and HUKUI Tech Work Together to Take AcuSense BioMedical Entering China Market

“Blood Leakage Detection System”, developed by AcuSense BioMedical Technology Corp. (AcuSense), is a specific medical device designed for kidney disease patient to reduce the risk of dialysis treatment. Through the cooperation with HUKUI Tech, the subsidy of Hukui Biotechnology Co., Ltd., AcuSense is going to expand its business to China. HUKUI Tech integrates product authorization, registration, production and distribution as…

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HUKUI Bio is Integrating its Network and Arranging Resource for Novel Coronavirus (COVID-19) Diagnostic Kit Supply Chain

In 2020, the epidemic of COVID-19 has spread in the whole world, and COVID-19 diagnostic kit is definitely a purchasing point from the beginning. HUKUI Bio has been authorized by two Taiwan nucleic acid diagnostic kit factories to begin providing COVID-19 diagnostic kit for Europe, ASEAN and South America markets, hoping to satisfy their local medical resources.

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Notes for Registration in China

What are the central authorities in charge of medical devices in various countries? United States  Food and Drug Administration (FDA) Attached to United States Department of Health, Education, and Welfare, is in charge of the administration of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies throughout the country. Taiwan  Taiwan Food…

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Clinical Guidelines in China

Are clinical trials necessary for medical devices to enter China? According to the 2018 announcement on the latest “Catalogue of medical devices exempted from clinical trials” (No. 94, 2018) and “Catalogue of IVD reagents exempted from clinical trials”, when the product description conforms to the medical devices or IVD reagents of the specification on the…

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Policy Guidelines in China

What are the norms for setting up a medical device factory in China? Good Manufacturing Practice for Medical Devices and YY0287-2017-Medical Devices-Quality Management Systems-Requirements for regulatory purposes / ISO 13485:2016 need to be followed. What is the current situation of centralized procurement of medical consumables? In March 2018, China changed the National Health and Family…

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Innovative Medical Devices in China

What are innovative medical devices? The core technology of the product has Chinese patent right for invention, or the application for invention patent has been reported to the Patent Administration Department under the State Council of China. The main working principle or action mechanism of the product is the first in China, and the product…

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